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Table 1 Baseline patient demographics and characteristics

From: Maraviroc, a chemokine receptor-5 antagonist, fails to demonstrate efficacy in the treatment of patients with rheumatoid arthritis in a randomized, double-blind placebo-controlled trial

 

Safety/PK component

POC component

 
 

Maraviroc 150 mg BID (n= 8)

Maraviroc 300 mg BID (n= 8)

Placebo

(n= 33)

Maraviroc 300 mg BID (n= 77)

Pvaluea

Female, number (percentage)

4 (50.0)

5 (62.5)

22 (66.7)

71 (92.2)

0.0014

Age in years

     

   Mean (SD)

58.5 (7.8)

56.6 (5.9)

53.4 (11.1)

53.6 (12.1)

0.9274

   Range

44-67

46-63

34-76

20-81

-

Race, number (percentage)

    

-

   White

8 (100.0)

8 (100.0)

21 (63.6)

51 (66.2)

 

   Black

0

0

0

3 (3.9)

 

   Asian

0

0

5 (15.2)

7 (9.1)

 

   Other

0

0

7 (21.2)

16 (20.8)

 

Weight in kg, mean (SD)

90.9 (30.4)

88.9 (13.9)

72.7 (16.9)

70.5 (15.4)

0.5173

Height in cm, mean (SD)

164.5 (11.1)

167.4 (4.8)

162.0 (9.7)

159.8 (7.6)

0.2057

BMI in kg/m2, mean (SD)

33.3 (10.2)

31.6 (4.0)

27.6 (5.5)

27.5 (5.4)

0.9670

Duration from first diagnosisb

    

0.9817

   Mean in years

11.0

11.9

7.8

7.9

 

   Range in years

3.0-22.3

2.5-29.0

0.6-32.0

0.4-40.0

 

ACR components, mean (SD)c

     

   Tender/painful joint count

-

-

17.5 (6.6)

16.4 (7.3)

0.3565

   Swollen joint count

-

-

12.8 (5.9)

11.5 (4.6)

0.2062

   Patient's assessment of arthritis pain

-

-

57.9 (26.0)

59.3 (20.6)

0.6375

   Patient's global assessment of arthritis

-

-

61.8 (26.1)

61.3 (21.2)

0.8932

   Physician's global assessment of arthritis

-

-

3.5 (0.7)

3.5 (0.7)

0.7926

   HAQ-DI

-

-

1.7 (0.7)

1.7 (0.6)

0.8405

   CRP

-

-

17.4 (19.0)

14.3 (13.2)

0.6946

DAS28-4 (CRP)c

-

-

6.0 (0.9)

5.8 (0.8)

0.4554

  1. aTwo-sample t test comparison for proof-of-concept (POC) component demographics. bTo day 1 of study. cAmerican College of Rheumatology (ACR) components and DAS28-4 (CRP) were not assessed at baseline for the safety/pharmacokinetic (PK) component. BID, twice daily; BMI, body mass index; CRP, C-reactive protein; DAS28-4 (CRP), disease activity score, 28-joint count, using C-reactive protein; HAQ-DI, health assessment questionnaire-disease index; SD, standard deviation.